MononeuropathiesSCIMONONCT06546371
Spinal Cord Stimulation for Intractable Mononeuropathy
A study testing Spinal cord stimulator in people with Mononeuropathies and Spinal Cord Stimulation, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mononeuropathies, Spinal Cord Stimulation
- What is being tested?
- Spinal cord stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 May 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)
- Symptoms refractory to conventional medical management for at least 6 months according to treating physician
- 18 years or older
- Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment)
- Stable or absent concomitant analgesics
Who cannot join
- Mononeuropathy located in the head or torso
- Mononeuropathy by avulsion at the plexus brachialis
- Life expectancy <1 year
- Anticoagulant drug therapy or disturbed coagulation
- Immune-compromised patients
- Pregnancy
- Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s)
- Patients with psychological factors or addiction that require treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Centre
Rotterdam, South Holland, 3015GD
Mathilde Scholtes, MSc, +31650032165, m.m.a.scholtes@erasmusmc.nl
About this study
Official title: Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study
Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the "Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients.
Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done.
Read more
Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre.
Study population: 12 patients suffering from intractable peripheral mononeuropathic pain.
Intervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months.
Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.
- Conditions
- Mononeuropathies, Spinal Cord Stimulation
- Being tested
- Spinal cord stimulator
- Medical subject headings
- Mononeuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulatorDevice
Electrical stimulation of the dorsal horn to reduce chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation | Experimental | Patients are all included in this experimental arm, where they receive all four stimulation options consecutively, but in different orders. After receiving all four stimulation options, the patients are allowed to choose which stimulation option of the four they want to have for the following period. Receives: Device: Spinal cord stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity.
Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable.
Measured: 6 months
Secondary outcomes (3)
Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST).
Quantitative sensory testing (QST) measures sensory thresholds for pain, touch, vibration, and temperature sensations, with the main goal to assess sensory functioning.
Measured: 6 months
Effect of SCS in patients with mononeuropathy on quality of life.
Quality of life as assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire.
Measured: 6 months
Patient preferences for SCS paradigms as assessed by the perceived pain intensity.
Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start13 May 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MononeuropathiesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mono-center explorative pilot study in 12 patients
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Prof. Dr. Frank Huygen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546371
- Sponsor's protocol ID
- MEC-2023-0644
- Acronym
- SCIMONO
- Status last verified
- Feb 2025
- First submitted
- 22 Jun 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study
- ClinicalTrials.gov ID
- NCT06546371
- Acronym / sponsor ID
- SCIMONO / MEC-2023-0644
- Conditions
- Mononeuropathies, Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 13 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the "Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients.
Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done.
Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre.
Study population: 12 patients suffering from intractable peripheral mononeuropathic pain.
Intervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months.
Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mono-center explorative pilot study in 12 patients
| Arm | Type | Receives |
|---|---|---|
| Spinal cord stimulation | Experimental | Device: Spinal cord stimulatorPatients are all included in this experimental arm, where they receive all four stimulation options consecutively, but in different orders. After receiving all four stimulation options, the patients are allowed to choose which stimulation option of the four they want to have for the following period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)
- Symptoms refractory to conventional medical management for at least 6 months according to treating physician
- 18 years or older
- Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment)
- Stable or absent concomitant analgesics
Key exclusion criteria (8 listed)
- Mononeuropathy located in the head or torso
- Mononeuropathy by avulsion at the plexus brachialis
- Life expectancy <1 year
- Anticoagulant drug therapy or disturbed coagulation
- Immune-compromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulatorElectrical stimulation of the dorsal horn to reduce chronic pain. | Device | Spinal cord stimulation |
Primary outcome
Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity.
Time frame: 6 months
Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable.
3 secondary outcomes
Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST).
Time frame: 6 months
Effect of SCS in patients with mononeuropathy on quality of life.
Time frame: 6 months
Patient preferences for SCS paradigms as assessed by the perceived pain intensity.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulator in people with Mononeuropathies and Spinal Cord Stimulation, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Scholtes, MSc (+31650032165, m.m.a.scholtes@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.